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Trial record 11 of 23 for:    cancer | Studies received from 04/22/2016 to 04/22/2016

An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02754141
First received: April 22, 2016
Last updated: August 15, 2017
Last verified: August 2017
  Purpose
The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

Condition Intervention Phase
Malignant Solid Tumor Biological: BMS-986179 Biological: Nivolumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Study of BMS-986179 Administered in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Number of adverse events (AE), serious adverse events (SAE), AEs leading to discontinuation, and deaths [ Time Frame: Up to 100 days after the last dose of study drug ]

Secondary Outcome Measures:
  • BMS-986179 enzyme assays in pre- and on-treatment biopsies [ Time Frame: Approximately 63 days ]
  • BMS-986179 immunohistochemistry (IHC) in pre- and on-treatment biopsies [ Time Frame: Approximately 63 days ]
  • Objective response rate (ORR) [ Time Frame: Approximately 2 years ]
  • Duration of response (DOR) [ Time Frame: Approximately 2 years ]
  • Progression free survival rate (PFSR) [ Time Frame: Approximately 2 years ]
  • Maximum observed serum concentration (Cmax) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Area under the serum concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Apparent terminal half-life (T-HALF) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Effective elimination half-life (T-HALFeff) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Trough observed serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Total body clearance (CLT) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Volume of distribution at steady state (Vss) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Accumulation index (AI) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Apparent volume of distribution of terminal phase (Vz) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Degree of fluctuation or fluctuation index (DF) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Frequency of positive anti-drug antibody (ADA) to BMS-986179 [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Frequency of positive anti-drug antibody (ADA) to nivolumab [ Time Frame: Up to 100 days after the last dose of study drug ]

Estimated Enrollment: 216
Actual Study Start Date: June 20, 2016
Estimated Study Completion Date: May 21, 2020
Estimated Primary Completion Date: March 11, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination Therapy with Monotherapy Lead-In (Dose-Escalation)
BMS-986179 leading to combination of BMS-986179 + nivolumab, dose as specified
Biological: BMS-986179
Specified dose on specified days, intravenous (IV)
Biological: Nivolumab
Specified dose on specified days, IV
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Combination Therapy (Pharmacodynamic Sub-study)
BMS-986179 + nivolumab, dose as specified
Biological: BMS-986179
Specified dose on specified days, intravenous (IV)
Biological: Nivolumab
Specified dose on specified days, IV
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Cohort Expansion Combination Therapy (Dose Expansion)
BMS-986179 + nivolumab, dose as specified
Biological: BMS-986179
Specified dose on specified days, intravenous (IV)
Biological: Nivolumab
Specified dose on specified days, IV
Other Names:
  • BMS-936558
  • Opdivo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Men and women at least 18 years of age
  • Advanced solid tumors
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Acceptable lab testing results
  • Allow biopsies

Exclusion Criteria:

  • Central nervous system (CNS) tumors
  • Uncontrolled or significant cardiovascular diseases
  • Active or known autoimmune disease
  • Organ transplant

Other protocol defined inclusion/exclusion criteria could apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02754141

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Dung Le, Site 0001    443-287-0002      
United States, New York
Columbia University Medical Center (Cumc) Recruiting
New York, New York, United States, 10032
Contact: Richard Carvajal, Site 0005         
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Howard Burris, Site 0004    615-329-7274      
Canada, Ontario
Local Institution Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Site 0003         
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Site 0002         
France
Local Institution Active, not recruiting
Toulouse Cedex 9, France, 31059
Local Institution Recruiting
Villejuif Cedex, France, 94805
Contact: Site 0007         
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Site 0006         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02754141     History of Changes
Other Study ID Numbers: CA013-004
2016-000603-91 ( EudraCT Number )
Study First Received: April 22, 2016
Last Updated: August 15, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017